Table 5. Incidence Rates and Incidence Rate Ratios of Serious Adverse Events in the First 12 Months by Registration Therapy and Eligibility Criteria.
| Variable | (95% CI) | |||
|---|---|---|---|---|
| Eligible | Ineligible | i-PASI | m-PASI | |
| Etanercept | ||||
| SAEs, No. | 42 | 36 | 9 | 2 |
| IR per 1000 | 226 (167-305) | 386 (279-536) | 249 (130-479) | 73 (18-293) |
| IRR | 1 [Reference] | 1.9 (1.40-2.60) | 1.0 (0.58-1.64) | 1.3 (0.80-2.03) |
| Adalimumab | ||||
| SAEs, No. | 131 | 34 | 65 | 18 |
| IR per 1000 | 269 (227-319) | 51 (367-719) | 271 (213-346) | 258 (163-410) |
| IRR | 1 [Reference] | 2.0 (1.55-2.59) | 0.9 (0.74-1.11) | 1.0 (0.71-1.30) |
| Ustekinumab | ||||
| SAEs, No. | 40 | 61 | 18 | 11 |
| IR per 1000 | 282 (207-384) | 630 (490-809) | 237 (149-375) | 382 (211-689) |
| IRR | 1 [Reference] | 2.8 (2.12-3.72) | 0.9 (0.65-1.37) | 1.7 (1.04-2.74) |
Abbreviations: IR per 1000, incidence rate per 1000 person-years; IRR, incidence rate ratio; i-PASI, insufficient baseline Psoriasis Area and Severity Index; m-PASI, missing baseline PASI; SAEs, serious adverse events.